Document QC: A discipline in its own right Download the webinar recording to learn more about the value of [...]

Nitrosamine Impurities in Medicinal Products Back to Kinapse blog In [...]

Kinapse welcomes you to ICH Q12 Back to Kinapse blog December 2020 Health Canada has recently released [...]

KASA System FDA’s regulatory assessment has evolved from a summary-based review to a question and risk-based review with an integrated quality assessment. [...]

Back to Kinapse blog Are you Brexit Ready? Do you know you only have 12 months to produce an eCTD baseline for your CAPs that have [...]

US Agent & Official Correspondent (OC) Services Download Kinapse US Agent flyer and learn more about our offerings. Download [...]

FDA Guidance for Industry: Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products Summary: The USFDA recently finalized the [...]

US Agent & Official Correspondent (OC) Services Are you planning to register and market your pharmaceutical, medical device or food and dietary [...]

Lessons Learnt from the Presence of N-nitrosamine Impurities in Sartan Medicines In 2018, the European medicines regulatory network became aware of [...]

Overview of the new Drug Regulation Registration (DRR) in China On the 1st July 2020 the new Drug Regulation Registration [...]

Kinapse welcomes you to ICH Q12 Back to Kinapse blog May 2020 The USFDA has recently released [...]

Kinapse welcomes you to ICH Q12 Back to Kinapse blog April 2020 On 9th April 2020, Swissmedic [...]

Back to Kinapse blog March 2020 On 4th March 2020, EMA published adoption of ICH Q12 guideline along with an [...]

Kinapse commits to supporting Marketing Authorisation Holders (MAHs) regarding Nitrosamine Impurities The deadline to respond to EMA Art. 5(3) Referral [...]

Back to Kinapse blog December 2019 Kinapse welcomes you to ICH Q12 The key milestone [...]